Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Evandro Chagas Institute of Clinical Research
Sponsor:
Collaborators:
Andrea Silvestre de Sousa, MD PhD
Alejandro Marcel Hasslocher, MD MSc PhD student
Andrea Pereira de Souza, PhD
Claudia Santos de Aguiar Cardoso, MSc
Patricia Dias de Brito, PhD
Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD
Roberta Olmo Pinheiro, PhD
Roberto Magalhães Saraiva, MD PhD
Sergio Salles Xavier, MD PhD
Paula Simplicio da Silva, MSc
Information provided by (Responsible Party):
Gilberto Marcelo Sperandio da Silva, Evandro Chagas Institute of Clinical Research
ClinicalTrials.gov Identifier:
NCT01863576
First received: May 22, 2013
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

The objective of this trial is to study the effects of omega-3 PUFA supplementation on the inflammatory response and lipid profile in patients with chronic Chagas cardiomyopathy.

Study Type: Interventional

Study Design: A total 40 patients will be randomly assigned into two parallel groups. The intervention will be treatment with omega-3 PUFAs at a dose of 3 g/day for 8 weeks, compared to placebo (corn oil). The primary endpoints will be the concentrations of inflammatory markers (IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β). Secondary endpoints will be the fasting glucose, lipid, and anthropometric profiles.


Condition Intervention Phase
Chagas Cardiomyopathy
Dietary Supplement: Omega-3
Dietary Supplement: Placebo Comparador
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
Official Title: Effects of Omega-3 Polyunsaturated Fatty Acid Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy: a Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Evandro Chagas Institute of Clinical Research:

Primary Outcome Measures:
  • Cytokine profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary endpoint of this study will be the cytokine profile. IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β will be measured in the serum of patients using specific sandwich enzyme-linked immunosorbent assays. Capture and detection antibodies will be obtained from eBioscience (San Diego, CA, USA).


Secondary Outcome Measures:
  • Lipid profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-c) will be measured with enzymatic-colorimetric assays using Siemens reagents on a Siemens Dimension RXL chemistry analyzer (Siemens Healthcare Diagnostics, Tarrytown, NY, USA). Low-density lipoprotein cholesterol (LDL-c) and VLDL-c will be calculated according to the Friedewald equation


Other Outcome Measures:
  • Anthropometric measures [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The anthropometric assessment will consist of body mass index (BMI), waist circumference, tricipital skinfold thickness, and arm circumference.


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omega-3
This group is receiving omega-3 supplement.
Dietary Supplement: Omega-3
The group omega-3 receives 5 capsules / day, each capsule containing 1100mg of lipids, and 600 mg of omega-3, 3g of omega-3 per day (1.8 g EPA and 1.2 g DHA) for a period of 8 weeks.
Other Names:
  • Oil fish
  • omega 3 fatty acids
  • polyunsaturated fatty acids
Placebo Comparator: Oil Corn
This group is receiving the placebo comparador.
Dietary Supplement: Placebo Comparador
The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.
Other Name: Oil Corn

Detailed Description:

Several studies have shown the beneficial effects of polyunsaturated fatty acids on inflammatory processes, dyslipidemia, and cardiovascular diseases, there are no reports about food intake and PUFA supplementation in chronic Chagas cardiomyopathy patients. Thus, the objective of this study is to assess the effects of omega-3 PUFA supplementation on the lipid profile and the pro-inflammatory and anti-inflammatory cytokine profiles in chronic Chagas cardiomyopathy patients.

After patients are selected by cardiologists, they will be seen by study nutritionists, who will explain the study procedures to the patients and administer the free and informed consent form. The patients who agree to participate in the study will sign the consent form and undergo the initial assessment.

The following data will be collected and evaluated in the study: sociodemographic data (age, sex, ethnicity/race, education, and domicile), clinical data (functional class and vital signs), alcoholism, smoking, prescription drugs, 3-day food record, 24-hour recall, anthropometric assessment (height, weight, BMI, waist circumference, tricipital skinfold thickness, and arm circumference), lipid profile (total cholesterol, triglycerides, HDL-c, LDL-c, and VLDL-c), and cytokines (IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β). Clinical, nutritional, and anthropometric assessments will take place immediately before starting the intervention and after 4 and 8 weeks during the study; lipid profile and cytokines will be evaluated before the intervention and at the end of 8 weeks. Each patient will be followed for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Volunteers with Chagas Cardiomyopathy at stage B (no heart failure symptoms but with segmental or global left ventricular systolic dysfunction), stage C (symptomatic heart failure), or stage D (end-stage heart failure)), according to the current Brazilian Chagas' Disease Consensus;
  • Subjects will include adults, men and women.

Exclusion Criteria:

  • diarrheal disease;
  • inflammatory bowel syndrome;
  • diagnosis of diabetes or other endocrine pathologies;
  • use of fibrates, niacin, or statins;
  • use of anti-inflammatory drugs;
  • pregnant and lactating women;
  • vitamin mineral or omega-3 supplementation during the previous 30 days;
  • hospital admission during the study;
  • presence of cardiomyopathies other than Chagas Cardiomyopathy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863576

Contacts
Contact: Gilberto Marcelo Sperandio da Silva MS Silva, PhD 55 21 38659595 gilberto.silva@ipec.fiocruz.br
Contact: Paula S Silva, MSc 55 21 38659602 paula.simplicio@ipec.fiocruz.br

Locations
Brazil
Evandro Chagas Institute of Clinical Research Recruiting
RJ, Br, Brazil, 21040-360
Contact: Paula S Simplicio, MSc    55 21 38659602    paula.simplicio@ipec.fiocruz.br   
Contact: Andrea S Sousa, PhD    55 21 38659595    andrea.silvestre@ipec.fiocruz.br   
Sub-Investigator: Paula S Silva, MSc         
Sponsors and Collaborators
Evandro Chagas Institute of Clinical Research
Andrea Silvestre de Sousa, MD PhD
Alejandro Marcel Hasslocher, MD MSc PhD student
Andrea Pereira de Souza, PhD
Claudia Santos de Aguiar Cardoso, MSc
Patricia Dias de Brito, PhD
Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD
Roberta Olmo Pinheiro, PhD
Roberto Magalhães Saraiva, MD PhD
Sergio Salles Xavier, MD PhD
Paula Simplicio da Silva, MSc
Investigators
Study Director: Andrea S Sousa, MD PhD Evandro Chagas Institute of Clinical Research
  More Information

No publications provided by Evandro Chagas Institute of Clinical Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilberto Marcelo Sperandio da Silva, PhD, Evandro Chagas Institute of Clinical Research
ClinicalTrials.gov Identifier: NCT01863576     History of Changes
Other Study ID Numbers: 0037.0.009.000-10
Study First Received: May 22, 2013
Last Updated: May 23, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Evandro Chagas Institute of Clinical Research:
Chagas disease
Chagas Cardiomyopathy
Trypanosoma cruzi
Omega-3
Cytokines
Lipid profile
Nutritional assessment

Additional relevant MeSH terms:
Chagas Cardiomyopathy
Cardiomyopathies
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014